1. Home
  2. Study
  3. Modules
  4. (BIOL 4302) Therapeutic Discovery and Development

Module Overview

Therapeutic Discovery and Development

Modern therapeutic discovery uses multidisciplinary project teams such as clinicians, chemists, molecular biologists, biologists, engineers and computer scientists in the discovery and development of novel therapeutics. This module will provide students with an understanding of the processes of new therapeutic discovery and development in the pharmaceutical (small molecule) and biopharma (biologic) sectors. Students will also learn about therapeutic registration, marketing and post-marketing responsibilities. This module will also expose students to current and future trends in therapeutic discovery and development.

Module Code

BIOL 4302

ECTS Credits

5

*Curricular information is subject to change

Lecture Programme

  • Introduction to pharmaceuticals, biologics, biopharmaceuticals.
  • The drug development process: an overview.
  • Target selection & Drug Interactions (small molecules and biologics).
  • Small molecule (incl. peptides) lead finding, lead optimization.
  • Current issues with small molecules (incl.peptides).
  • Impact of genomics and proteomics on the drug discovery process.
  • Current biologics such as proteins, vaccines, antibodies, aptamers, gene and cell therapy
  • Clinical development of biotech products/pharmaceuticals: clinical trials, phases 0 – IV, trial design and protocols, trial size, population, legal aspects, Good Clinical Practice(GCP).
  • National and International Legal Frameworks: the role of regulatory authorities.European regulations: national regulatory authorities, EMEA and new drug approval systems, centralized/decentralized procedures. Regulations US (FDA): investigational new drug (IND) application and new drug application (NDA). Orphan drugs: orphan drug act.
  • Future Directions: such as advanced drug delivery or bispecific antibodies.
  • Personalised medicine and its role in drug development

 

Case-studies

  • Case studies from industry will be examined and presented to supplement certain topics and to illustrate interpretation of regulations.
  • Students will also undertake a case study of the development of a therapeutic to a relevant disease

The course will be delivered by lectures including possible guest lectures, web-based materials, case studies involving class discussion and participation;

A total of 57 hours self-directed learning is required and tutorial/review sessions will also be provided

Module Content & Assessment
Assessment Breakdown %
Formal Examination60
Other Assessment(s)40